水飞蓟宾粉针质量标准及安全性评价研究

Quality standard and preliminary secure research on silybin powder for injection

探讨注射用水飞蓟宾葡甲胺质量标准及初步安全性评价研究.实验针对该剂的干燥失重、不溶性微粒、炽灼残渣以及安全性评价中的溶血、刺激、过敏反应进行研究.该制剂的回归曲线为Y=47 741X+531.19,r=0.999 9.精密度:测得平均峰面积为11 182.42,RSD为0.479 6%.稳定性试验表明在14 h内稳定性良好,RSD为1.030 9%.加样回收率:平均回收率为99.84%,RSD为0.593 5%.样品质量分数测定:质量分数均在标示量95%-105%范围内,平均含量40.749 9 mg/支.检查的其他项目符合药典的有关规定.试验证明此质量标准符合国家药典有关规定,在实际生产中可有效指导生产的进行.

To research the quality standard and preliminary secure research of silybin-meglumine for injection. This paper carries on by the weight loss, insolubility particle, ignition dregs, content determining and hemolysis, penicillin allergy, irritating of preliminary secure. The results indicated that regression curve was Y=47 741X ＋531.19,r = 0. 999 9; the precision：average peak area 11 182. 42,RSD 0. 479 6% （n =6） ; stability： the stability which RSD was 1. 030 9% in 14 hours ; The average recovery was 99.84%, the RSD was 0. 593 5% . The sample average content was 40. 749 9 mg/bottle. Every item in the experiment was fit in with the pharmacopoeia and the quality standard can be the reference to the production .